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Whistleblower Can’t Use Discovery Info to Satisfy Rule 9(b)

Rule 9(b) requires a whistleblower alleging fraud to “state with particularity the circumstances constituting fraud.” Tom Bingham provided the particularity, but his case was nevertheless dismissed because of the way he came...more

AGG Food and Drug Newsletter - October 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

3D Printing Quarterly Report: Q3 - 2016

Study offers plan to make Northeast Ohio region the Silicon Valley of 3D printing - A report from the Youngstown Business Incubator and America Makes in Youngstown and Team NEO and Magnet in Cleveland offers a plan to...more

GME benefits of rural status

When Congress first established limits on Medicare payments for graduate medical education (GME) in the Balanced Budget Act of 1997, the resident limits or "caps" on Medicare-funded training positions applied equally to all...more

Omnicare Inc. Settles Kickback Allegations for $28 Million

The United States Justice Department (DOJ) announced this week that Omnicare, Inc. (Omnicare), the largest nursing home pharmacy in the United States, will pay approximately $28 million dollars to resolve charges that it...more

Employer Obligations Under New Nondiscrimination Rules: ACA Section 1557 and Requirements for Federal Contractors

Two new regulations require some employers to make health plan design and administrative changes. While not all employers are subject to these requirements, those who are will need to review their plans and be aware of other...more

MACRA Final Rule released: CMS gives an abundance of flexibility in transition to keep providers in the game

In a rare example of bipartisanship in health care policy, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10) was passed by Congress and signed into law on April 16, 2015. Members of Congress...more

New Non-Discrimination Notice Requirements Go Into Effect October 17, 2016

In May of this year, the Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) finalized its rulemaking implementing certain non-discrimination requirements under Section 1557 of the Affordable...more

When Outside Compliance Monitors May Be a Blessing: Companies Subjected to Corporate Integrity Agreements May Be Undone by Rogue...

Companies face ever-increasing pressures to implement mechanisms designed to prevent or effectively address employee malfeasance. In today’s environment, even companies who appear to be cooperating with investigative and...more

Tenet Healthcare Will Pay $513 Million To Resolve Criminal Charges And Civil Claims

Tenet Healthcare Corporation, an investor-owned healthcare services company based in Texas, and two of its Atlanta-based subsidiaries have entered into an agreement with the government to resolve criminal charges and civil...more

Washington Healthcare Update

This Week: Congress remains in recess, but members write letters on Mylan’s EpiPen…CBO says repealing Part B Demo would cost $395 million…CMS releases data on hospice utilization and finds spending and utilization vary in...more

Congress is focused on FTE caps: New proposed legislation would redistribute hospitals’ unused residency training slots

There has been recent activity in Congress surrounding full-time equivalent (FTE) residency training caps (FTE caps) that limit the number of Medicare-funded graduate medical education (GME) training positions for which a...more

Supreme Court Punts Again on FCA Claims Specificity

The U.S. Supreme Court recently denied certiorari in United States ex rel. Walterspiel v. Bayer AG. This case, arising out of the Fourth Circuit, raised yet again the question of how much detail a False Claims Act (FCA)...more

False Claims Act Developments Significantly Impact a Broad Range of Industries Doing Business with the U.S. Government

No other area of government enforcement or civil liability has experienced anything quite like the three dramatic developments in initiation, penalties and standards for False Claims Act cases over the last twelve months. FY...more

Health Care Company to Pay $514 Million to Settle Kickback Allegations

Tenet Healthcare Corp. has agreed to pay states and the federal government $514 million to settle allegations that its hospitals in Georgia and South Carolina paid kickbacks for obstetric referrals. This massive settlement...more

Former CEO of Health System Agrees to Pay $1 Million to Settle False Claims Act Case with U.S. Department of Justice

In the most recent example of its continued effort to hold individuals accountable for corporate misconduct, the U.S. Department of Justice (“DOJ”) announced on September 27, 2016, that the former CEO of Tuomey Healthcare...more

Corridors - October 2016 - News for North Carolina Hospitals

Proposed 2017 Hospital OPPS Rule Would End Medicare Payments to Many Off-Campus Facilities at the Same Levels as Hospital-Based Outpatient Departments - Published on July 14, 2016, CMS’s proposed 2017 Hospital...more

Executives Beware: CEO Pays $1 Million Out of His Own Pocket To Resolve False Claims Act Matter

Ralph “Jay” Cox III, the former Chief Executive Officer of Tuomey Healthcare Systems (“Tuomey”) in Sumter, South Carolina, recently paid $1 million to settle his involvement in Tuomey’s illegal billing practices under...more

CMS Releases Nursing Facility Mega-Rule

The Centers for Medicare and Medicaid (“CMS”) this week released its long-awaited nursing facility “Mega-Rule,” the most comprehensive revision of CMS’s requirements for nursing homes since 1991. CMS said that the new...more

7th Circuit Requires Objective Standards When Pleading Medical Necessity Under the FCA

The Seventh Circuit recently added an arrow to a False Claims Act (FCA) defendant's quiver by requiring relators to plead fraud allegations based on objective criteria pursuant to Fed. R. Civ. P. 9(b). This ruling will...more

Recent Significant Case Law Developments Regarding What Constitutes a Reckless Interpretation of a Law and When Retention of an...

Key Points: - Learn the latest case law developments regarding what evidence the government or the relator must establish to prove that the defendant “recklessly” interpreted a statute or regulation in violation of the...more

Insights Conversations: How Government Health Care Investigations May Be Shifting

The Department of Justice (DOJ) has long had the advantage when investigating False Claims Act (FCA) cases against health care companies. However, recent changes in the courts, including a unanimous U.S. Supreme Court...more

October 17th Compliance Deadline for HHS Nondiscrimination Notifications Approaches

On May 18, 2016, the United States Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published a final rule implementing Section 1557 of the Affordable Care Act. Among other topics, the final...more

Notable False Claims Act decision in California attempts to restrict Escobar

Last Tuesday, September 20, 2016, the US District Court for the Northern District of California held that the Supreme Court’s decision in Universal Health Services, Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989...more

When Will Trust Assets Be Considered Available Assets When Applying For Medicaid In Connecticut?

A recent Connecticut Supreme Court decision, Pikula v. Department of Social Services (SC 19533; released May 10, 2016), confirms the guidelines for determining if trust assets are considered “available assets” for purposes of...more

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